On February 14, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported its new preclinical data on SNS-101, a conditionally active, pH-selective VISTA-blocking antibody, at Next Generation Antibody Therapeutics: From Discovery to Patient, organized by Keystone Symposia, being held February 19-22, 2023 in Banff, Alberta, Canada (Press release, Sensei Biotherapeutics, FEB 14, 2023, View Source [SID1234627210]). The presentation will be made by Sensei’s Chief Scientific Officer, Dr. Edward van der Horst.

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Presentation Details:

Title: SNS-101, a conditionally active anti-VISTA antibody, potentiates anti-tumor effects of PD-1 blockade and displays favorable pharmacokinetic and cytokine release characteristics
Presenter: Edward van der Horst, Ph.D., Chief Scientific Officer
Session: Conditional Targeting with Multi-Specific Engagers
Date and time: Monday, February 20, 2023 between 9:00-11:15 a.m. MST

Material from the presentation will also be presented in a poster at the conference, as detailed:
Poster Number: 2027
Session: Poster Session 2
Date and time: Tuesday, February 21, 2023 at 7:30 p.m. MST

On February 14, 2023 Prelude Therapeutics presents its corporate presentation (Presentation, Prelude Therapeutics, FEB 14, 2023, View Source [SID1234627207]).

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On February 14, 2023 Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, reported that it plans to issue its fourth quarter and fiscal year 2022 financial results after the U.S. equity markets close on February 27, 2023 (Press release, Perrigo Company, FEB 14, 2023, View Source,-2023,-Conduct-Virtual-Investor-Day-on-February-28,-2023 [SID1234627206]). As a reminder, the Company plans to host its Virtual Investor Day on February 28, 2023, beginning at 8:00 AM EST. All interested parties are invited to access the event at View Source and are encouraged to register in advance.

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On February 14, 2023 Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis ("NASH") and other diseases with significant unmet medical needs, reported certain preliminary financial results as of and for the year ended December 31, 2022 (Press release, Inventiva Pharma, FEB 14, 2023, View Source [SID1234627203]).

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Preliminary Financial Results1

Cash and cash equivalents, short-term deposits, R&D Expenses, Net cash used in operating activities, Net cash generated from investing activities and Net cash generated from financing activities.

As of December 31, 2022, the Company had €86.7 million of cash and cash equivalents and €1.0 million of short-term deposits1, compared to €61.2 million and €11.4 million, respectively as of September 30, 2022, and €86.6 million and €8.8 million, respectively, as of December 31, 2021.

Cash and cash equivalents at year end included the €12.8 million upfront payment (including €1.3 million of withholding taxes, amounting to net proceeds of €11.5 million) received on November 4, 2022 from Chia Tai Tianqing Pharmaceutical Group, Co., LTD ("CTTQ"), a subsidiary of Sino Biopharm, in connection with the previously announced licensing and collaboration agreement dated September 21, 2022.

Cash and cash equivalents at year end also included the €25.0 million tranche of the previously announced unsecured loan agreement executed with the European Investment Bank ("EIB") on May 16, 2022, which the Company received on December 8, 2022, the €9.3 million gross proceeds (€8.8 million net proceeds) raised through the Company’s At-The-Market ("ATM") Program on June 15, 2022, and the proceeds of three previously announced loan agreements with a syndicate of French banks for a total amount of €5.3 million. One of the loans was contracted as part of a French state-guaranteed loan facility with Bpifrance, and the two other loans were obtained as part of a French state stimulus economic plan granted by Crédit Agricole Champagne-Bourgogne and Société Générale.

Research and development ("R&D") expenses for the fourth quarter of 2022 increased generally in line with the increase recorded during the first three quarters of 2022, and amounted to €60.5 million for the full year 2022, compared to €48.5 million in 2021. This increase was driven mostly by the costs associated with the NATiV3 Phase III clinical trial of lanifibranor in NASH, including a full twelve months of operation for the U.S. affiliate and, to a lesser extent, with the LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes ("T2D").

Net cash used in operating activities amounted to (€44.9) million for the full year 2022, compared to (€47.7) million in 2021. Net cash used in operating expenses in 2022 was driven primarily by R&D expenses, partially offset by the upfront payment received from CTTQ.

Net cash generated from (used in) investing activities amounted to €8.9 million for the full year 2022 compared to (€1.8) million net cash used for the same period in 2021. The variance is mainly due to the change in short term deposits between both periods.

Net cash generated from financing activities amounted to €37.3 million for the full year 2022 compared to €25.4 million for 2021. Net cash generated from financing activities in 2022 has been driven by the proceeds of the first tranche of €25 million from the EIB loan, proceeds of €9.3 million from the sale of securities through the Company’s ATM program and proceeds of €5.3 million from three French state partially guaranteed loans, as described above.

For the full year 2022, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€1.0) million versus a positive effect of €4.8 million for 2021, due to the strengthening of USD versus Euro.

Considering its current R&D and clinical development programs, the Company estimates that its existing cash, cash equivalents and short-term deposits should allow the Company to fund its operations through the fourth quarter of 20232. This cash runway estimate does not include the conditional second tranche of €25.0 million of the EIB loan agreement3.

Revenues

The Company’s revenues for the full year 2022 amounted to €12.2 million, as compared to €4.2 million for 2021. The revenues recorded in 2022 were driven mostly by the Company’s development agreement with CTTQ, executed on September 21, 2022, and revenues recorded in 2021 primarily consisted of a €4.0 million milestone payment for a milestone that was recorded following the launch by AbbVie of the Phase IIb clinical trial with cedirogant. As previously disclosed, this trial of cedirogant has since been discontinued by AbbVie and the partnership with AbbVie has been terminated.

Next key milestones expected

Publication of the topline results of the investigator-initiated study with lanifibranor in patients with Non-Alcoholic Fatty Liver Disease ("NAFLD") and T2D – planned for the first quarter of 2023
Publication of the topline results of the LEGEND Phase IIa combination trial of lanifibranor in combination with empagliflozin in patients with NASH and T2D – planned for the second half of 2023
Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating lanifibranor in NASH – targeted for the second half of 2023
Upcoming investor conference participation

Cowen 43rd Annual Health Care Conference – March 6-8 – Boston, MA
Guggenheim Health Altitudes Summit 2023 – March 13-16 – Telluride, Colorado
Evercore ISI NASH Renaissance – March 30 – Virtual
Kempen Life Sciences Conference – April 25-26 – Amsterdam
Upcoming scientific conference participation

Global NASH – March 2-3 – London
AEEH – March 15-17 _ Madrid
Liver Connect conference – March 23-26 – Huntington Beach , CA
AASLD Emerging topic: NASH Cirrhosis from mechanisms to management – March 25-26- Los Angeles, CA
Next financial results publication

Full-Year 2022 financial results: Wednesday, March 29, 2023 (after U.S. market close)

On February 14, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported that it has entered into a clinical trial agreement with the National Cancer Institute (NCI), an institute of the National Institutes of Health, to evaluate an autologous T cell therapy expressing a T cell receptor targeting mutated KRAS in combination with Gritstone’s KRAS-directed vaccine candidate, SLATE-KRAS, in a Phase 1 study (Press release, Gritstone Bio, FEB 14, 2023, View Source [SID1234627201]). The study will be led by Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI’s Center for Cancer Research.

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"We are privileged to establish this collaboration with NCI and Dr. Rosenberg, a pioneer of cancer immunotherapy and an expert in cell therapy," said Andrew Allen, M.D., Ph.D, Co-founder, President & Chief Executive Officer of Gritstone bio. "To date, cell therapy’s success in treating blood cancers has not translated to the more common solid tumors. There is a mechanistic synergy in having cell therapy and cancer vaccines in combination. We are thrilled to test this hypothesis in patients in collaboration with a leader in the cell therapy field. We look forward to collaborating with Dr. Rosenberg and his team to generate proof-of-concept data from this promising study."

Under the terms of the agreement, NCI will identify patients with metastatic cancer that are eligible for adoptive cell transfer based on the presence of a G12V or G12D KRAS mutation (KRASmut). Gritstone will provide the SLATE-KRAS vaccine as requested by NCI for the trial.

"The use of neoantigen vaccines to enhance the potency of neoantigen-directed T cell therapy is an attractive concept with supportive pre-clinical data," said Karin Jooss, Executive Vice President & Head of R&D at Gritstone bio. "Our KRAS-directed vaccine has demonstrated the ability to induce and expand KRASmut-specific T cells and drive them into solid tumors in multiple clinical studies. Combining this modality with autologous KRASmut-specific TCR transduced T cells (TCR-T), as delivered by Dr Rosenberg in his clinical program at the NCI, is a rational approach to augmenting therapeutic efficacy. As a leader in the development of cancer neoantigen vaccines, we believe this approach to potentially deepening and extending the therapeutic effect of TCR-T could provide improved outcomes to solid tumor patients."

An "off the shelf" neoantigen vaccine candidate, SLATE-KRAS demonstrated early evidence of efficacy as defined by molecular response in immune checkpoint blockade (ICB)-resistant/refractory subjects in the Phase 2 portion of an ongoing Phase 1/2 study (NCT03953235). Based on the results to date from the Phase 1/2 study, Gritstone has elected to initiate a separate, randomized Phase 2 study evaluating SLATE against a KRASmut-driven tumor type. Gritstone expects to initiate this separate, randomized study in the second half of 2023.